Methods and devices for manipulating and fastening tissue

ABSTRACT

Stomach tissue is manipulated and fastened with a tissue grasper and a tissue shaper to form folds in the stomach. The tissue grasper and the tissue shaper rotate and translate relative to one another. The tissue grasper has a plurality of vacuum orifices to adhere the tissue grasper to tissue.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. applicationSer. No. 13/229,452, filed Sep. 9, 2011 by Richard Romley. Thisapplication is also related to U.S. application Ser. No. ______, filedMar. 7, 2013 (Our Ref. No. 2234-104-B) and U.S. application Ser. No.______, filed Mar. 7, 2013 (Our Ref. No. 2234-104-C) both by RichardRomley et al., which are all hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates to methods and devices for manipulatingand fastening tissue. In particular, the present invention may be usefulin treating gastroesophageal reflux disease (GERD).

Referring to FIG. 2, a normal stomach and esophagus are shown with adisease state shown in the dotted line position. GERD develops in thedisease state since the gastroesophageal flap valve at the junction orintersection between the esophagus and stomach has deteriorated so thatstomach contents can splash into the esophageal tract resulting in GERD.The disease state is associated with a shorter esophageal tract and asomewhat enlarged stomach. The junction has also moved orally therebyeffectively shortening the esophageal tract as well.

SUMMARY OF THE INVENTION

The present invention provides devices and methods for manipulating andfastening tissue together. The device includes numerous aspects, whichmay be practiced by themselves or in combination with other aspects ofthe invention. The device will be described in connection with treatingGERD but shall have applications in other fields as well.

The device includes a shaft and a tissue displacing element coupled tothe shaft. The tissue displacing element is configured to reshapestomach tissue. The stomach tissue is then fastened together to form afold. When treating GERD the fold is formed at the intersection of theesophageal tract and stomach.

In one aspect of the invention, a plurality of tissue displacingelements are coupled to the shaft. The displacing elements arepreferably individually and independently movable. The device may alsoinclude a common retractor, which is configured to displace the tissuedisplacing elements simultaneously. When used to recreate the junctionbetween the esophagus and stomach, the common retractor may be moveddistally along the shaft to lengthen the fold of tissue. The device mayinclude a lock, which couples two tissue displacing elements togetherwhile maintaining the ability to independently move, or maintainstationary, the third element. In this manner, two of the tissuedisplacing elements may be simultaneously moved while at least onetissue displacing element remains stationary.

The tissue displacing element may include an elongate element, such as awire, having an engaging element, such as a helical coil, at the distalend. Once the coil is rotated into tissue, the tissue is displaced byapplying tension to the wire. The wire may have a curved distal portionso that rotation of the wire changes a position and angular orientationof the wire. A sheath may be slidable over the wire to cover and uncoverthe distal portion of the wire. The shape of the distal portion changeswhen the sheath covers and uncovers the wire thereby providing greaterflexibility in directing the coil to engage a particular stomachlocation.

In another aspect of the invention, the device may include a tissueshaper coupled to the shaft. Tissue may be moved into the tissue shaperby simply moving the tissue displacing element to draw tissue into thetissue shaper. Alternatively, tissue may be moved into the tissue shaperby moving only the tissue shaper or the tissue shaper and the tissuedisplacing element simultaneously. The shaper has a cavity with an openproximal end leading to the cavity. Alternatively, the open end may beat the distal end leading to the cavity. The tissue displacing elementmay be movable within the cavity and to positions proximal and distal tothe cavity. The tissue shaper may also be removable from the shaft andreplaceable with another shaper. The shaft may include a primary shaftand a secondary shaft, which are slidable relative to one another, thetissue shaper being coupled to the primary shaft and the tissuedisplacing element being coupled to the secondary shaft.

The tissue shaper may also be partially or completely resilient so thatthe cavity may be expanded and to provide compression on tissue astissue enters the cavity. The elastomeric portion may be positioned atthe proximal open end of the cavity so that the proximal end may expandto accommodate tissue. The cavity may also include an elastomericportion adjacent a midportion of the cavity. The flexibility of thetissue shaper may also be enhanced by providing a plurality oflongitudinal slits in the tissue shaper. The device may also include atension sensor coupled to the tissue displacing element. The tensionsensor measures tension on the tissue displacing element developedduring displacement of tissue.

The shaft may include a vacuum orifice configured to adhere the shaft totissue. The vacuum orifice may be used to grasp the esophageal tract.The vacuum orifice may be used to stabilize tissue displaced by thetissue displacing element so that the tissue displacing element may bereleased and repositioned to displace another part of the stomach whilethe vacuum orifice holds previously displaced stomach tissue.

The device may also include a tissue shifting element configured toshift tissue held by the shaper. The tissue shifting element may beconfigured to engage a stomach side of the fold and displace the stomachside of the fold distally thereby moving the intersection of the folddistally. Alternatively, the tissue shifting element may displace bothtissue layers such as the esophageal side and the stomach side whentreating GERD. Another tissue shifting element may be provided forshifting the esophageal side (radially inner side) further into thetissue shaper either independently or simultaneously with the stomachside (radially outer side). The tissue shifting element displaces tissueto increase a length of the fold of tissue while the fold of tissue ispositioned in the cavity. The tissue shifting element may also drawtissue into the shaper while shifting tissue already held by the shaper.

The device may include a fastener applier which is a separate devicedelivered down a fastener lumen in the shaft. The fastener applier mayinclude a fastener cartridge containing a plurality of fasteners and maydeliver a plurality of fasteners in a single actuation. The fastenercartridge may apply a compressive force to the fold of tissue prior toapplication of the fastener.

The common retractor may include a slot in which the tissue displacingelement is positioned so that the central axis of the wire translateswithin the slot. Movement within the slot changes an angular position byat least 45 degrees with respect to the longitudinal axis of the shaftwhen moving within the slot. The change in angular position provided bythe slot may be accomplished without moving the shaft.

The tissue shaper may also draw tissue through an open distal end forforming a fold at an intersection of the stomach and the esophagusadjacent the lesser curvature. The tissue shaper is positioned in theesophagus and the fold is released so that the stomach tissue positionedin the tissue shaper falls back into the stomach. The tissue shaper mayhave a convex side facing inward relative to the esophagus to create aconvex side of the fold. The fastener is applied to the fold beforerelease above the junction between the esophageal tract and the stomachalong the greater curvature side and preferably at least 3 cm above.

In another aspect of the present invention, a tissue grasper is providedwhich has an elongate body that defines a longitudinal axis and has anouter surface. A plurality of vacuum orifices are positioned on theouter surface of the elongate body to form a sealing surface to adherethe outer surface of the elongate body to tissue using suction. Theplurality of vacuum orifices may be separated into a first section and asecond section with both sections both extending partially around theouter surface of the elongate body when viewed along the longitudinalaxis. The first and second sections together form a circumferentialsealing surface. For example, the first section may extend around 270degrees while the second section extends around 90 degrees around thebody.

The tissue grasper may also include a third section rotatable about thelongitudinal axis relative to the first and second sections. The thirdsection may extend less than 100 degrees around the outer surface whenviewed along the longitudinal axis. A fourth section may also beprovided similar to the third section and also rotatable (and maylongitudinally translate as well) relative to the first, second andthird sections. The third and fourth sections are also movable to thesame longitudinal position and may be positioned to create a window in agap between the third and fourth sections. The window may be placed at afastener application site.

The tissue grasper may also have a tissue piercing element to helpsecurely hold tissue. The tissue piercing element is contained in arecess extending below the outer surface of at least one of theplurality of vacuum orifices. The tissue piercing element is movablebetween a stored position and a working position. The piercing elementhas a sharp tip to pierce tissue when tissue is drawn into the recessthrough the at least one vacuum orifice using suction. The tissuepiercing element moves out from the recess to engage tissue when movingfrom the stored position to the working position. In one aspect, thesharp tip extends no more than 4 mm from the outer surface of theelongate body when in the working position. The recess may be a slothaving sidewalls that guide the tissue piercing element.

In still another aspect of the present invention, a reinforcing elementis provided to reinforce the folds and, in particular, the posterior andanterior ends of the fold. The reinforcing element has a first side anda second side with one side attached to the anterior side and the otherattached to the posterior side of the stomach on the lesser curvatureside of the stomach. The reinforcing element may be mounted to thetissue grasper, or a separate delivery device, to expose the first andsecond sides for application of a fastener. The reinforcing elementremains attached to the elongate body after the first (and/or second)side is attached to tissue for controlling the tissue attached to thereinforcing element using the tissue grasper. The reinforcing elementmay include a woven element having an interstitial space configured toreceive a fastener. The reinforcing element may also include areinforced polymer sheet. The reinforcing element may also includeeyelets which receive the fasteners.

A first tissue shaper may be provided and coupled to the tissue grasper.The first tissue shaper has a first shaft rotatably coupled to theelongate body. The first tissue shaper is also longitudinallytranslatable relative to the elongate body. The first tissue shaper hasa first tissue displacing element to draw tissue into a first cavity inthe first tissue shaper. The first cavity may be formed by a mold thatis pivotally coupled to the first shaft with the cavity being formedtherebetween. A second tissue shaper may also be provided which has asecond shaft extending through the elongate body. The second tissueshaper is also rotatable about the longitudinal axis relative to thefirst tissue shaper and the tissue grasper. The second tissue shaperforms a second cavity with a second mold that is pivotally coupled tothe second shaft. A second cavity formed by the second tissue shaper isformed between the second mold and the first shaft.

These and other features and aspects of the invention will becomeapparent from the following description of the preferred embodiment,drawings and claims.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 shows a device for manipulating and fastening tissue of thepresent invention.

FIG. 2 shows a stomach and an outline of the stomach in a disease state.

FIG. 3 shows the device inserted into the stomach and a tissue engagingelement extended to engage stomach tissue.

FIG. 4 shows a perspective view of the device.

FIG. 5 is a cross-sectional view of the device at line A-A of FIG. 4.

FIG. 6 is a cross-sectional view of the device of FIG. 5 with guidetubes moved within slots to translate the tissue displacing elements.

FIG. 7 shows the range of motion provided by the tissue displacingelement and the range of motion provided when the sheath is used.

FIG. 8 shows a tissue shifting element in a stored position.

FIG. 9 shows the tissue shifting element engaging one tissue layer ofthe tissue fold.

FIG. 10 shows the tissue shifting element engaging both tissue layers ofthe tissue fold.

FIG. 11 shows a fastener applier, which may be used with the presentinvention.

FIG. 12 shows another fastener applier.

FIG. 13A shows another fastener applier prior to delivery of thefastener.

FIG. 13B shows the fastener of FIG. 13A delivered into the tissue fold.

FIG. 14 shows still another fastener applier.

FIG. 15 shows the device delivered into the stomach and positioned in adesired location to recreate the intersection between the stomach andesophageal tract.

FIG. 16 shows a second tissue displacing element engaging stomachtissue.

FIG. 17 shows the first and third tissue displacing elements engagingstomach tissue after retracting stomach tissue with the second tissuedisplacing element.

FIG. 18 shows the first and third tissue displacing elements retractingstomach tissue after engagement with tissue in FIG. 17.

FIG. 19 shows the second tissue displacing element disengaged fromstomach tissue, reengaged with stomach tissue and retracted again whilethe first and third tissue displacing elements maintain the tissue fold.

FIG. 20 shows all three tissue displacing elements engaged with tissueand positioned proximate a common retractor.

FIG. 21 shows all three tissue displacing elements engaged with tissueand retracted to the common retractor.

FIG. 22 shows three tissue displacing elements simultaneously displacedinto the tissue shaper using the common retractor.

FIG. 23 shows all three tissue displacing elements retracted further bythe common retractor.

FIG. 24 shows fasteners applied to the stomach to create a tissue foldin accordance with the present invention.

FIG. 25 show another view of the stomach where additional fasteners havebeen applied to the tissue fold.

FIG. 26 shows the tissue displacing element engaged with stomach tissue.

FIG. 27 shows the tissue displacing element retracted to displace tissuetoward the tissue shaper.

FIG. 28A shows the tissue displacing element moved within the slot todisplace tissue toward an end of the tissue shaper.

FIG. 28B shows the tissue displacing element of FIG. 28A moved into thetissue shaper.

FIG. 29 shows the second tissue displacing element engaged with tissueafter displacement in accordance with FIGS. 26, 27, 28A and 28B

FIG. 30 shows the second tissue displacing element moving tissue withthe first and third tissue displacing elements prior to displacementtowards the ends of the shaper.

FIG. 31 shows tissue extending through an open distal end of the shaperfor manipulation by the tissue displacing elements.

FIG. 32 shows the device with a removable tissue shaper attached to theshaft.

FIG. 33 shows the device with another tissue shaper attached to theshaft.

FIG. 34 shows the device with still another tissue shaper attached tothe shaft.

FIG. 35 shows another device for manipulating and fastening tissue.

FIG. 36 shows the tissue shaper positioned in the esophageal tract.

FIG. 37 shows a fold formed with the device of FIG. 35.

FIG. 38 shows another device for manipulating and fastening tissue.

FIG. 39 shows a tissue shifting element.

FIG. 40 shows a mold in a partially closed position.

FIG. 41 shows the mold closed with the tissue shifting element movingmore tissue into the tissue shaper.

FIG. 42 shows a tissue grasper.

FIG. 43 is a cross-sectional view of the tissue grasper with tissuepiercing elements in a stored position.

FIG. 44 is a cross-sectional view of the tissue grasper with tissuepiercing elements in a working position.

FIG. 45 shows another device for manipulating and fastening tissue.

FIG. 46 shows a first tissue shaper closed and a second tissue shaperfully extended.

FIG. 47A shows the first and second tissue shapers in closed positions.

FIG. 47B shows a fastener.

FIG. 48 shows another device for manipulating and fastening tissue.

FIG. 49 shows the concentrically mounted sections of the tissue grasper.

FIG. 50 is a cross-sectional view of the tissue piercing element of thethird and fourth sections of the tissue grasper.

FIG. 51 shows a reinforcing element.

FIG. 52 is a cross-sectional view of the reinforcing element.

FIG. 53A shows the reinforcing element mounted to the tissue grasper.

FIG. 53B is another view of the reinforcing element mounted to thetissue grasper.

FIG. 54A is a cross-sectional view of the tissue piercing element andthe reinforcing element mounted to a collar.

FIG. 54B shows the reinforcing element released.

FIG. 55 is a diagram of a fold with the reinforcing element extendingfrom the anterior side to the posterior side at the ends of the fold.

FIG. 56 is a diagram illustrating methods of the present invention.

FIG. 57 is another diagram depicting methods of the present invention.

FIG. 58 is still another diagram of methods of the present invention.

FIG. 59 illustrates shifting tissue from the radially inner side to theradially outer side.

FIG. 60 illustrates shifting tissue from the radially outer side to theradially inner side.

FIG. 61 illustrates another method of using the reinforcing element.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1, 4 and 5, a device 2 for manipulating and fasteningtissue is shown. The device 2 and various aspects thereof may be used tomanipulate and fasten tissue anywhere in the body. In particular, thedevice 2 of the present invention may be used to manipulate stomachtissue to recreate the intersection between the stomach and theesophageal tract.

The device 2 includes a tissue shaper 4 which shapes tissue into adesired shape such as a gastroesophageal flap valve. The device 2 hasfirst, second and third tissue displacing elements 6, 8, 10 which gatherand manipulate tissue into a cavity 50 in the tissue shaper 4. Thetissue displacing elements 6, 8, 10 are coupled to a common retractor 12having a platform 14 which may be used to simultaneously move the tissuedisplacing elements 6, 8, 10 as described below. The tissue shaper 4 iscoupled to a shaft 15 consisting of a flexible primary shaft 16 and aflexible secondary shaft 22 and may be releasably coupled to the shaft15 as described below. The shaft 15 defines a longitudinal axis 18 andangular orientations and displacements are often defined and describedherein as being relative to the longitudinal axis 18. For example,referring to FIG. 6, an angle B is defined between the first and secondtissue displacing elements 6, 8 as defined relative to the longitudinalaxis 18. The longitudinal axis 18 may be substantially straight or maybe curved without departing from the scope of the invention so long asthe longitudinal axis 18 generally follows and defines the orientationof the shaft 15. The primary shaft 16 terminates at the proximal end ata lock 20 which locks and seals the primary shaft 16 to the secondaryshaft 22. When the lock 20 is unlocked, the primary and secondary shafts16, 22 may be moved relative to one another. The primary and secondaryshafts 16, 22 are movable relative to one another so that the commonretractor 12 and platform 14 are movable as shown by the solid anddotted line positions of FIG. 1 although the common retractor 12 hasgreater range of motion than depicted in both directions. A plurality ofvacuum orifices 23 are positioned on the primary shaft 16 to grasptissue, such as the esophageal tract, as also described below. Thevacuum orifices 23 are coupled to a suction source 25 through a spacebetween the first and second shafts 16, 22.

The tissue shaper 4 forms a fold of tissue which is substantiallysimilar to a natural gastroesophageal flap valve. To this end, thetissue shaper 4 forms a generally tubular structure open on both ends,the esophagus on one side and the stomach on the other. The generallytubular structure may also have an open side proximate the esophagus ormay be a substantially closed shape. Referring to FIGS. 5 and 6, thetissue shaper 4 has a generally curved cross-sectional shape terminatingat a first end 24 and a second end 26. The curved cross-sectional shapeforms an arc of at least 180 degrees relative to the longitudinal axisbetween the first and second ends 24, 26. The tissue shaper 4 alsodefines a central plane 28 (FIG. 6) which lies equidistant from thefirst and second ends 24, 26 and/or may define an axis of symmetry whenviewed along the longitudinal axis 18. The second tissue displacingelement 8 lies on the central plane 28 but may be offset from the plane28 as well.

The tissue shaper 4 may, of course, take other suitable cross-sectionalshapes such as oval, round, or V-shaped without departing from the scopeof the invention and it is understood that these shapes also would havea central plane as defined herein. Furthermore, the tissue shaper 4 mayalso be omitted without departing from various aspects of the presentinvention. For example, the tissue displacing elements 6, 8, 10 alonemay be used to displace stomach tissue and form a fold of tissue bysimply displacing the tissue in a manner which forms the fold of tissuewithout requiring the tissue shaper 4. The tissue may be displaced intothe shaper 4 without moving the shaper 4 and using only elements 6, 810, moving only the tissue shaper 4, or moving both the elements 6, 8,10 and shaper together.

Referring to FIG. 7, the tissue displacing elements 6, 8, 10 eachinclude a tissue engaging element 30, such as a helical coil 32, whichis rotated to pierce and engage tissue as is known in the art. The coil32 is coupled to an elongate element 34, such as a wire 35, and theelongate element 34 is covered by a retractable sheath 36. The elongateelement 34 may have a curved shape which permits the user to direct thedistal end in a desired direction by simply rotating element 30. Thesheath 36 may be advanced over the wire 35 to change the shape of thedistal portion to provide a broader range of motion to direct the coil32 as desired. FIG. 7 shows the elongate element 34 bent further by thesheath 36, however, the sheath 36 could also straighten the elongateelement 34. Furthermore, the elongate element 34 or sheath 36 may besubstantially straight, rather than bent, without departing from thescope of the invention.

As will be described further below, the tissue engaging elements 6, 8,10 may be used to displace tissue substantially longitudinally when thewire 35 is retracted. The elements 6, 8, 10 may be retracted into andextended from the shaft as shown throughout the Figures. The curvedshape of the wire 35 may also provide an angular displacement (change inorientation) with respect to the longitudinal axis 18 of at least 45degrees when the element 6, 8, 10 is retracted. Stated another way, theelements 6, 8, 10 may apply an angular displacement of at least 45degrees relative to the ends 24, 26 of the tissue shaper 4 (in additionto longitudinal displacement) when the wire 35 is retracted. This aspectof the invention will be described in greater detail below. The angulardisplacements or change in angular orientation is accompanied bylongitudinal displacement toward the patient's feet and into the stomachof at least 5 cm and is typically 2 to 6 cm.

Once the helical coil 32 has engaged tissue as shown in FIG. 3, tensionis applied to the elongate element 34 to move the stomach tissue towardthe tissue shaper 4. The elongate element 34 may be coupled to a tensionsensing element, such as a simple spring element 41 shown in dotted linewith only element 8, which displays an indication of tension on theelongate element at an indicator 40. Use of the tension indicators 40 isdescribed below in connection with use of the device 2. The tissueengaging element 6, 8, 10 may grip tissue using any other suitablemethod including graspers or a suction gripper without departing fromthe scope of the invention. A twist lock 42 is provided to lock each ofthe tissue displacing elements 6, 8, 10 at any suitable positionrelative to the secondary shaft 22 and maintain tension on the elongateelements 34.

Referring to FIG. 16, in one aspect of the present invention, one of thetissue displacing elements 6, 8, 10, such as the second tissuedisplacing element 8, may be displaced until a threshold tension isreached at which time the user applies the appropriate lock 42 (seeFIG. 1) to lock the tissue displacing element 8 as shown in FIG. 17. Asalso shown in FIG. 17, the user may manipulate another of the elements6, 10 until another threshold tension or displacement is reached atwhich time the user again applies the appropriate lock 42 as shown inFIG. 18. The second tissue displacing element 8 may then be disengaged,moved, reengaged with tissue and retracted again as shown in FIG. 19. Inthis manner, the user may continue to individually displace each of thetissue displacing elements 6, 8, 10, while maintaining engagement withthe other elements until the desired shape is achieved. The tensionindicators 40 may be used with any method described herein even when notexpressly described.

The first and third tissue displacing elements 6, 10 are also movablewithin elongate slots 44 in the platform between the position of FIG. 5near the ends 24, 26 of the shaper 4 to the position of FIG. 6 closer tothe second element 8. The sheath 36 and elongate element 34 arepositioned in guide tubes 46 which are movable in the slots 44 bymanipulating pull wires 48. The pull wires 48 are coupled to an actuator50, such as a control knob 51, which is simply rotated to move both pullwires 48 thereby moving the guide tube 46 within the slot 44. A lockingbutton 53 is provided to lock each of the control knobs 51 to fix theposition of the pull wires 48 and therefore fix the position of theguide tube 46 anywhere along the slot 44.

The slot 44 permits the tissue displacing element 6, 10 to be moved sothat a central axis 56 of the elongate element 34 is displaced at least45 degrees relative to the longitudinal axis 18 when viewed along thelongitudinal axis 18 as shown in FIG. 6 and represented by angle C.Stated another way, a portion 35 (FIG. 1) of the elongate element 34positioned at the slot 44 which emerges from shaft 15 changes angularposition by at least 45 degrees with respect to the longitudinal axis18. Movement in this manner is typically not possible with conventionalmulti-link arms and graspers which have a base which may pivot but isfixed in translation relative to the shaft.

The slots 44 may also lie generally on a plane defined by the platform14 which is substantially perpendicular to the longitudinal axis 18 ofthe primary shaft 16. Stated still another way, the slots 44 permit thetissue displacing elements 6, 8, 10 to change an angle B formed betweeneach of the first and third tissue displacing elements 6, 10 and thesecond tissue displacing element 8, or the central plane 28, by at least45 degrees relative to the longitudinal axis 18. In this manner, theslots 44 may be used to displace tissue toward and away from the ends24, 26 of the tissue shaper 4. The elongate element 34 may be retractedinto the guide tube 46 so that the helical coil 30 is positioned at theslot 44 (see FIGS. 27 and 28). When the coil 30 is positioned at theslot 44, translation of the coil 30 in the slot 44 shifts tissue withoutlongitudinal displacement which is useful in various methods describedbelow.

The tissue shaper 4 of FIG. 4 is configured to shape a fold of tissue torecreate a gastroesophageal flap valve. The tissue shaper 4 has a cavity50 which receives the tissue. As mentioned above, the tissue can bemoved into the cavity 50 by moving the elements 6, 8, 10 or shaper 4alone or by moving the shaper 4 and elements 6, 8, 10 together.

Referring to FIG. 4, the tissue shaper 4 may include an elastomericportion 52 on a proximal portion 54 of the tissue shaper 4 which permitsthe cavity 50 to expand to accommodate tissue. The elastomeric material52 is positioned at a proximal opening 56 of the cavity 50 so that theopening 56 can elastically expand thereby facilitating introduction of alarger tissue volume while applying a modest compressive force to tissueat the opening 56. The tissue shaper 4 will also increase compression ontissue contained in the cavity 50 as the tissue volume increases. Thetissue shaper 4 has an outer wall 58 which may have a plurality of slits60 formed therein to further increase the flexibility of the tissueshaper 4 and permit expansion of the cavity 50. The slits 60 extend fromthe proximal end 62 and extend toward a distal end 64 of the tissueshaper 4. The distal end 64 of the tissue shaper 4 also has a distalopening 65 to permit the tissue to extend through the tissue shaper 4 asdescribed below in connection with use of the device 2. The tissueshaper 4 may be a substantially fixed structure except for theelastomeric portion 52, however, the elastomeric portion 52 does providesome movability to the tissue shaper 4 in that the cavity 50 has a firstvolume during introduction which is less than a volume of the cavity 50when tissue is introduced into the expandable cavity 50. As such, thetissue shaper 4 does change shape even though the tissue shaper 4 is notmovable by the user. Although the tissue shaper 4 is shown as astructure, which is not moved by the user, the tissue shaper 4 may bemovable by the user to close the tissue shaper 4 (not shown) around thefold of tissue without departing from numerous aspects of the presentinvention.

Referring now to FIG. 32, a removable tissue shaper 4A is attached to aprimary shaft 16A. The tissue shaper 4A may be removably attached to theshaft 15 in any suitable manner such as a simple snap-fit connection 117or bayonette connection (not shown). Referring to FIGS. 33 and 34, twomore tissue shapers 4B, 4C are shown with the tissue shapers 4A, 4B, 4Cbeing interchangeable and usable in any manner that tissue shaper 4 isused. The user may decide upon which tissue shaper 4A, 4B, 4C to useprior to beginning the procedure and attach the appropriate tissueshaper 4A, 4B, 4C to the shaft 16A. Alternatively, the user may beginthe procedure with one of the tissue shapers 4A, 4B, 4C and may decideto change to another shaper (different shape and/or size). The presentinvention provides the ability to change shapers 4A, 4B, 4C or selectthe appropriate shaper 4A, 4B, 4C from available shapes and sizes.

The tissue shaper 4, 4A may have substantially straight edges, formingan acute angle, symmetrically disposed about the longitudinal axis 18(see FIG. 1 and FIG. 16). Alternatively, the profile edges could beconvex or concave, or any combination of concave, convex or straightedged profiles as now discussed in connection with tissue shapers 4B, 4Cof FIGS. 33 and 34. Referring to FIG. 33, for example, tissue shaper 4Bhas a convex outer wall 55B which creates a cavity 50B also having aconvex outer wall 57B. A proximal opening 56B leading to the cavity 50Bhas a smaller cross-sectional shape than a midportion 59B of the cavity50B. In this manner, the cavity 50B may be sized to hold the fold oftissue more loosely in the midportion 59B so that the tissue in themidportion 59B may be manipulated more easily within the cavity 50Bwhile the tissue fold is still being firmly held by the proximal opening56B. Use of elastomeric portion 52B may be particularly advantageous inholding tissue firmly at the proximal opening 56B.

Referring to FIG. 34, tissue shaper 4C has a concave outer wall 55C anda cavity 50C having a concave outer wall 57C. The cavity 50C has aproximal opening 56C, a distal opening 65C and a midportion 59C. Themidportion 59C has the smallest cross-sectional shape throughout thecavity 50C so that tissue contained in the cavity 50C may be held morefirmly by the midportion 59C. An elastomeric portion 52C of the shaper4C may be adjacent the midportion 59C which provides the advantagesdescribed above in connection with tissue shaper 4. Holding tissuewithin the shaper 4C in this manner may facilitate gathering tissueusing various methods described herein. For example, the tissue shaper4C may hold the fold of tissue firmly at the midportion 59C so thattissue near the distal opening 65C and extending through the distalopening 65C may be manipulated.

The tissue shaper 4C also includes a first clamping element 61 and asecond clamping element 63 (shown in dotted-line position). The firstand second clamping elements 61, 63 may be elastic balloons 75 but maybe any other suitable mechanism such as a pivoting jaw. FIG. 34 showsthe balloons 75 partially inflated to clamp tissue contained in thetissue shaper 4C. The first clamping element 61 is positioned near thedistal end and the second clamping element 63 is positioned along themidsection although any number of clamping elements (including only one)may be used. An inflation lumen 79 is coupled to the balloons 75 andextends through the connector 117 but may be a separate lumen as well.It is understood that the clamping elements 61, 63 may be incorporatedinto any of the other tissue shapers 4, 4A, 4B and use of the clampingelements 61, 63 with the any of the other tissue shapers 4, 4A, 4B isexpressly incorporated here.

The clamping element 61, 63 may be used to hold tissue contained withinthe tissue shaper 4C and may be clamped and unclamped as desired. Assuch, the balloons 75 may be deflated during the tissue displacing stepsand inflated to hold tissue after the displacing step. Thus, all methodsdescribed herein may include deflating the balloon 75 prior todisplacing tissue and/or may include inflating the balloon 75 after eachdisplacing step. The clamping elements 61, 63 may also be used to holdtissue during application of fasteners and, to this end, each methoddescribed herein may include the step of clamping the tissue foldtogether before fastening the fold together. The clamping element 61, 63may be released and again reapplied before each fastening step asdesired and, again, all methods described herein shall expressly providefor the clamping steps described herein.

As mentioned above, the common retractor 12 and platform 14 are coupledto the secondary shaft 22 so that the platform 14 may be moved relativeto the shaper 4. Movement of the secondary shaft 22 and the platform 14also moves all three of the tissue displacing elements 6, 8, 10simultaneously. The secondary shaft 22 includes lumens 66 which receivethe tissue displacing elements 6, 8, 10 and pull wire lumens 68 whichreceive the pull wires 44 for the guide tubes 46 (FIGS. 5 and 6). Asuction lumen 70 may also be provided which is coupled to vacuumorifices 72 in the platform 14. The vacuum orifices 72 and vacuumorifices 23 in the primary shaft 16 are coupled to a suction source 71as shown in FIG. 1 and are independently controllable as is known in theart.

A visualization lumen 74 is formed between the primary and secondaryshafts 16, 22 in which a visualization device 76 may be positioned. Thevisualization device 76 may be any suitable device and suitable devicesare described in U.S. Pat. No. 7,583,872, Compact Scanning Fiber Deviceand U.S. Pat. No. 6,275,255, Reduced Area Imaging Devices. In one aspectof the present invention, the lumen 74 which receives the visualizationdevice 76 is no more than 10% of a total cross-sectional area of theshaft 15. In one embodiment, the visualization lumen 74 may have adiameter of about 5 mm and the primary shaft 16 has a cross-sectionalarea of about 255 mm2. A lock 75 is also provided to couple movement ofthe first and third tissue displacing elements 6, 10 together asdescribed below in connection with various methods of the presentinvention.

The tissue, or parts, thereof, may be stabilized or engaged within thetissue shaper 4, or even outside the tissue shaper 4, using the tissuedisplacing elements 6, 8, 10, the vacuum orifices 72 in the platform 14or the vacuum orifices 23 on the primary shaft 16. Furthermore, it isunderstood that stabilizing tissue between tissue manipulations orfastening steps with any one of these elements may be practiced with anyof the methods described herein even if not specifically described. Forexample, some methods of the present invention describe stabilizingtissue with the second tissue displacing element 8 while moving tissuewith the first and/or third tissue displacing elements 6, 10 and suchmethods may be practiced by stabilizing tissue with any other suitableelement such as the vacuum orifices 23 on the primary shaft 16 or vacuumorifices 72 in the platform 14 and such methods are expressly includedas part of the invention.

The tissue shaper 4 may be sized to firmly hold the fold of tissue oncethe fold of tissue has been drawn into the cavity 50 while stillpermitting some movement of the tissue within the tissue shaper 4.Shifting tissue within the tissue shaper 4, as used herein, shall meanthat the tissue shaper 4 holds the fold of tissue so that at least partof the tissue is approximated and in contact with one another prior tofastening but are still held loosely enough to shift tissue within thetissue shaper 4 and/or draw tissue into the tissue shaper 4.

Referring to FIGS. 8-10, one structure which may be used to move orshift tissue within the tissue shaper 4 is a tissue shifting element110. The tissue shifting element 110 is coupled to the tissue shaper 4and provides a mechanism for shifting tissue within the tissue shaper 4without moving the tissue shaper 4 and preferably without moving theprimary or secondary shafts 16, 22. The tissue shifting element 110includes a pair of needles 112 mounted on a wire 114. The needles 112may be coupled to the wire in any suitable manner; for example, theneedles may pivotally engage the wire 114 or may have an integrallyformed hinge with the wire 11. The device 2 may include two sets ofneedles 112. One set of needles 112A may pierce one tissue layer (FIG.9) and the other set of needles 112 may penetrate both layers of thetissue fold (FIG. 10). Each wire 114 extends through a tube 116 havingan open slit 118 through which the needles 112, 112A extend. When thewire 114 is advanced to the position of FIG. 8, the needles 112 arecollapsed within the tube 116. When the wire 114 is moved proximally,the needles 112 naturally expand outwardly through the slit 118 andfurther proximal motion causes the needles 112, 112A to penetrate one orboth tissue layers. The tissue shifting element 110 may engage thetissue with any other suitable mechanism including a movable suctionport. Tissue may also be shifted within the tissue shaper 4 usingelements 6, 8, 10 which may apply longitudinal and/or angulardisplacements as described herein. For example, the elements 6, 8, 10may displace tissue further into the cavity 50 and displace tissuetowards or away from the ends 24, 26 of the shaper 4 by moving theelements 6, 10 within slots 44. As such, the displacing elements 6, 8,10 may also constitute tissue shifting elements for shifting tissuewithin the tissue shaper 4 as used herein. The tissue shifting element110 is omitted for clarity in various drawings but all drawingsincluding the tissue shaper 4 shall be interpreted to include the tissueshifting element 110.

Any suitable fastener may be used with the present invention and, infact, numerous aspects of the present invention may be practiced withany other suitable fastening method such as adhesive or suture. Severalsuitable fastener appliers are described below in connection with FIGS.11-14. Although the fastener applier is a separate device delivered downthe fastener lumen 74, numerous aspects of the present invention may bepracticed with the fastener applier being integrated into the device 2rather than being a separate device. An advantage of providing aseparate fastener applier is that the device 2 may be advanced down thepatient's esophagus without the fastener applier positioned in thefastener lumen 74 which may provide a more flexible device forintroduction than would a device having the fastener applier integratedinto the device 2. The fastener lumen 78 includes a window 80 in theprimary shaft 16 so that the fastener may be applied anywhere along anarc of at least 90 degrees, and may be at least 120 degrees, relative tothe longitudinal axis 18 without moving the shaft 15 or the tissueshaper 4. The fastener lumen 74 may also include a ramp 80 which causesthe fastener applier to be displaced radially outward from thelongitudinal axis 18 to compress the fold of tissue prior to delivery ofthe fastener as described below and shown in FIG. 12.

Referring now to FIG. 11, a fastener applier 90 is shown. The fastenerapplier 90 includes a cartridge 92 containing a plurality of fastenerssuch as staples 94. An actuator 96 is coupled to a firing mechanismwhich is actuated to deploy the fasteners in any suitable fashion as isknown in the art. The fastener applier 90 may be configured to deliver aplurality of staples 94 simultaneously and, in particular, in alongitudinal orientation. Different cartridges 92A, 92B may be providedto dispense a different number or orientation of staples 94 as desiredand methods of the present invention may provide for sequential use ofthe cartridges 92, 92A, 92B. The fastener applier 90 may also belongitudinally movable with respect to the tissue shaper 4 and theprimary shaft 16 so that the fastener applier 90 may be used atdifferent longitudinal positions without moving the primary shaft 16and/or the tissue shaper 4. Numerous aspects of the present inventionmay be carried out with the tissue fold being fastened in any suitablemanner including use of an adhesive or conventional suture rather thandiscrete fasteners. Additional aspects of the fastener applier 90 aredescribed in connection with use of the device.

Another fastener applier 96 is shown in FIG. 12. The fastener applier 96contains a helical fastener 98 which is rotated into engagement withtissue using an actuator 99. The fastener applier 96 has an open distalend 100 which is directed toward the tissue by the ramp 80 to furthercompress the tissue fold prior to application of the fastener 98. Thehelical fastener 98 is rotated and advanced with the actuator 99 so thata sharp tip 102 penetrates and advances into the tissue fold. Afterapplication of the helical fastener 98, another fastener applier 96 isused or another fastener 98 is delivered down the same applier 96.

Referring to FIGS. 13A and 13B, yet another fastener applier 101 isshown which delivers a helical fastener 103. The fastener 103 has asharp tip 113 and form a number of coils 115 which define an axis 117.The fastener 103 is oriented longitudinally within a shaft 105 of theapplier but is deployed in a manner which reorients the axis 117 upondeployment. An actuator 107 rotates and advances the helical fastener103 which causes the helical fastener 103 to contact a deflectingelement 109 which deflects the fastener 103 outwardly from the shaft 105and into tissue. As the helical fastener 103 is deployed, the deflectingelement 109 causes the axis 117 to be displaced at least 45 degrees fromthe stored position within the shaft to the deployed position outsidethe shaft 105.

Referring to FIG. 14, still another fastener applier 121 is shown whichdelivers a plurality of helical fasteners 123. The fasteners can bedelivered sequentially or simultaneously. The helical fasteners 123forms a plurality of coils 129 which define an axis 131 and a lengthmeasured along the axis 131. The helical fasteners 123 are deployedthrough one or more side openings 125 upon movement of a rack 127 thatrotates a gear 135 coupled to the fasteners 123 so that simplelongitudinal motion of the rack 127 rotates all of the fastenerssimultaneously. The fasteners 123 may be compressed in a stored positionwithin the shaft 125 so that a natural unbiased length of the fastener123 is at least 1.5 times, or even 2.0 times, a stored length (orcompressed length) SL of the fasteners 123 within the shaft. As thefastener 123 is deployed, the fastener 123 naturally expands toward thenatural unbiased length. In another aspect, the opening 125 may beoriented to direct the fastener 123 into an even larger length than theunbiased length by simply applying a greater pitch upon delivery throughthe opening. In this manner, the coils 129 are initially expanded sothat tissue between the coils is compressed as the fastener 123 isdeployed. For example, the fastener applier 121 may be configured todeploy the fastener 123 at a deployed length DL which is 2.5 times thestored length SL while the relaxed or unbiased length is 2.0 timeslarger than the stored or compressed length SL.

Methods of using the device 2 are now described. As will be appreciated,the present invention provides great flexibility in the manner in whichthe fold of tissue is formed and fastened together. As such, all methodsof forming the fold shall be applicable to all methods of fastening thetissue together and such combinations are expressly included as part ofthe present invention even if not expressly described. Furthermore, allmethods of manipulating tissue which are described in connection withmoving tissue within or into the tissue shaper 4 may be practicedwithout the tissue shaper 4 or below the tissue shaper 4 and all suchmethods are expressly incorporated herein.

The device 2 is delivered down a patient's esophagus into the positionof FIG. 15 so that the tissue shaper 4 is distal to the existingintersection between the esophageal tract and the stomach associatedwith a disease state. The visualization device 76 is used to view thestomach and orient the tissue shaper 4 within the stomach so that thetissue shaper 4 is positioned to create the fold of tissue in thedesired position. An advantage of the present invention is that the usermay not need to reposition the tissue shaper 4 once the desired positionhas been chosen. Of course, numerous aspects of the present inventionmay be practiced while moving the tissue shaper 4 between differentpositions without departing from the scope of the invention. Forexample, the tissue shaper 4 could be used to gather and fasten tissueinto a fold and could be rotated to another position to create anotherfold.

At least one of the tissue displacing elements 6, 8, 10, such as thesecond tissue displacing element 8, is then extended outwardly to engagestomach tissue as shown in FIG. 3. The sheath 36 may be extended tocover the wire 35 to change the shape of the wire 35 to provide adifferent shape to facilitate engaging the desired stomach tissuelocation (see FIG. 7). The coil 32 is then rotated to engage the stomachtissue. Referring to FIGS. 1, 3 and 16, the second tissue displacingelement 8 may then be pulled to draw stomach tissue toward the tissueshaper 4 which increases tension on the elongate element 34 andregisters at the tension indicator 40. The user may refer to the tensionindicator 40 to assist in assessing formation of the fold and the forceswhich may be required to maintain the fold. The user may retract thetissue displacing element 8 until a threshold tension is reached atwhich time the lock 42 is applied to maintain tension as shown in FIG.17. The user may then engage stomach tissue with another of the elements6, 10, such as the first element 6, and retract tissue until anotherthreshold tension is reached, or desired displacement is achieved, andthe appropriate lock 42 is applied as shown in FIG. 18. This process maybe repeated until the stomach tissue has been displaced a desired amountby each of the tissue displacing elements 6, 8, 10 (see FIGS. 19 and20).

An advantage of the present invention is that a stepwise displacement oftissue is possible since the plurality of elements 6, 8, 10 permit oneof the elements 6, 8, 10 to be disengaged from tissue while the othertwo elements 6, 8, 10 substantially maintain the shape of the previouslydisplaced tissue. In this manner, one of the elements 6, 8, 10, such asthe second element 8, may be disengaged, repositioned to engage stomachtissue and displaced again as shown in FIGS. 18 and 19. The displacedstomach tissue may also be held by the vacuum orifices 23 in the primaryshaft 16 (FIG. 1), the vacuum orifices 72 in the platform 14 (FIG. 5)and/or the tissue shaper 4 in addition to, or as a substitute for, thefirst and third tissue displacing elements 6, 10 which hold the tissuein a displaced state of FIG. 18. During displacement of stomach tissue,the elements 6, 8, 10 may displace the tissue by simply applying tensionto the wire 35 and/or moving them within the slots 44 (FIGS. 5 and 6).For example, the first tissue displacing element 6 may be retracteduntil the coil 32 is proximate to the platform 14 followed by movementwithin the slot 44 to change the angular orientation as describedherein.

Once the user has engaged tissue with each of the tissue displacingelements 6, 8, 10 and displaced each of the tissue displacing elements6, 8, 10 as desired, the user may simultaneously displace all of thetissue displacing elements 6, 8, 10 using the common retractor 12 (seeFIG. 21) to draw all three tissue displacing elements 6, 8, 10 into thetissue shaper 4 (see FIGS. 22 and 23). Suction may be applied to theorifices 72 in the platform 14 (FIG. 5) which may assist in drawing thetissue into the tissue shaper 4 as the common retractor 12 is moved intothe tissue shaper 4. Of course, the tissue displacing elements 6, 8, 10may be used to individually draw tissue into the tissue shaper 4, ratherthan using the common retractor 12 to simultaneously move all tissuedisplacing elements 6, 8, 10, without departing from the presentinvention. This may be accomplished by simply positioning the platform14 in the cavity or even distal to the shaper 4 so that tissue is drawninto the tissue shaper 4 by the tissue displacing elements 6, 8, 10alone (see FIG. 31).

Referring again to FIG. 8, the fold of tissue is shown contained withinthe tissue shaper 4. The fold of tissue forms the intersection betweenthe esophageal tract and the stomach and has an esophageal side 131 anda stomach side 133 although at least some of the tissue on theesophageal side 131 may be characterized as stomach tissue prior tocreation of the fold due to the disease state as described above. Thetissue shaper 4 is sized to hold the fold of tissue and may be adaptedto expand to a larger volume to accommodate the fold tissue due to theelastomeric portion 52 and the slits 60 (FIG. 4). Once the tissue iscontained within the tissue shaper 4, the fold may be manipulated as nowdescribed or any other manner described herein.

The fold of tissue in the shaper 4 may be manipulated using the tissueshifting element 110 as shown in FIGS. 8-10. The needle 112 and/orneedle 112A pierce one or both layers of the tissue fold and the wire114 is then pulled proximally thereby moving the needles 112 downward todraw more tissue into the tissue shaper 4 and shift tissue downwardwithin the shaper 4. The tissue shifting element 110 may also change aposition of the intersection between the stomach and the esophagealtract to increase a length of the esophageal tract. When only one tissuelayer is engaged as shown in FIG. 9, the tissue shifting element 110displaces only the stomach side 133 of the fold while the esophagealside 131 is held stationary by the vacuum orifices 23 on the primaryshaft 15 (see FIG. 1). The tissue may also be shifted within the tissueshaper 4 using the elements 6, 8, 10. In this manner, the tissuedisplacing elements 6, 8, 10 serve as tissue shifting elements inaccordance with the present invention. For example, the tissuedisplacing elements 6, 8, 10 may be used to displace the tissue furtherinto the cavity 50 or through the open distal end 65 of the tissueshaper 4 (see FIG. 31). The tissue displacing elements 6, 8, 10 may alsobe moved within the slots 44 to shift and displace tissue within thetissue shaper 4 in any manner described herein. The tissue displacingelements 6, 8, 10 may all be used to apply longitudinal displacement aswell as a change in angular position relative to the longitudinal axissimilar to use of the slots 44.

Methods of fastening the fold of tissue together and additional methodsof manipulating the tissue are now described. Each of the fasteningmethods may be used with any of the methods of manipulating tissue andforming the fold described herein. For the purpose of describing thesemethods, fasteners F1, F2, F3, F4, F5, F6, F7 are shown in FIGS. 24 and25. Fasteners F1, F2 are longitudinally aligned at one end of the tissuefold (formed near the end 24 of the tissue shaper 4) and F6, F7 are atthe other end of the tissue fold (and formed near the other end 26 ofthe tissue shaper 4). Fasteners F3-F5 are longitudinally aligned along acentral portion of the fold of tissue. Of course, more or fewerfasteners may be applied and any of the fastener appliers describedherein or any other suitable fastener applier may be used with orintegrated with the device 2. As mentioned above, the clamping elements61, 63 may be used to clamp the fold of tissue during application offasteners and all methods described herein may include application ofthe clamping elements 61, 63 during each fastening step. The clampingelements 61, 63 may be released if further tissue displacing steps arecarried out followed by application of the clamping elements 61, 63before applying another fastener.

In one aspect of the present invention, the fastener applier 90 of FIG.11 is used to deliver a plurality of fasteners, such as the staples 94,simultaneously. Once the fold of tissue is held in the desired shape, asshown in FIG. 23 for example, the fasteners F1, F2 may be appliedsimultaneously with the fastener applier 90 positioned at position P1 ofFIG. 6. Fasteners F3, F4, F5 are applied at position P2 and fastenersF6, F7 are applied at position P3. Three separate fastening appliers 90may be used to simultaneously apply each row of fasteners or onefastener applier 90 may be used to apply all of the fasteners in threeseparate steps using different preselected cartridges 92, 92A, 92B. Whenonly one fastener applier 90 is used, the fastener cartridge 92 may bechanged after each row of fasteners is applied. If the fastener applierhas enough fasteners, the fastener applier 90 is simply rotated withinthe window 80 to the next appropriate location and the next set offasteners 94 is applied. The fastener cartridge may be adapted todispense the necessary amount of fasteners 94 at each application.

The fasteners 1-7 may be applied after all tissue manipulations havebeen completed. Alternatively, some of the fasteners F1-F7 may beapplied and the tissue is further manipulated with the elements 6, 8, 10or shifting element 110 followed by application of more fasteners F1-F7.This process may be repeated until all of the fasteners F1-F7 areapplied while the user manipulates tissue between each fastening step asdesired. The vacuum orifices 23 in the shaft 15 or the vacuum orifices72 in the platform 14 may be used to further stabilize the fold oftissue between the fastening steps. The tissue shaper 4 itself may alsohelp to firmly hold the fold of tissue (particularly if the elastomericportion 52 is used) yet still permits shifting of tissue within thetissue shaper 4 and still permits tissue to be drawn into the tissueshaper 4. Various methods of manipulating tissue with the device 2 mayinclude holding selected parts of the tissue fold stationary whiletissue is manipulated with another part of the device 2. To this end,the vacuum orifices 23 in the shaft 15, the vacuum orifices 72 in thecommon retractor 23, the tissue displacing elements 6, 8, 10 and eventhe tissue shifting elements 110 may be used to hold parts of the tissuestationary while other parts of the device 2 are used to furtherdisplace the tissue in any manner described herein.

In one example of a procedure having a number of fastening and tissuemanipulation steps, fasteners 1, 2 and fasteners 6, 7 at the ends 24, 26of the tissue shaper 4 are applied first followed by application offasteners 3, 4, 5 along the central portion of the tissue shaper 4. Inthis manner, the tissue fold is created at the ends 24, 26 of the tissueshaper 4 first followed by formation of the central portion of the fold.Referring to FIGS. 26-28, the third tissue displacing elements 10 (andthe first tissue displacing element 6 in similar fashion on the oppositeside) extends outwardly to provide for longitudinal and an angulardisplacement upon retraction as described herein. The first and thirdtissue displacing elements 6, 10 may also be manipulated within theslots 44, such as toward the ends 24, 26 of the tissue shaper 4, asshown in FIGS. 27-28. In this manner, tissue has been drawn towards theends 24, 26 of the tissue shaper 4. The tissue is the drawn into theshaper 4 by moving the first and third displacing elements in any mannerdescribed herein to the dotted line position of FIG. 28. The fasteners1, 2 and 6, 7 may then be applied near the ends 24, 26 of the tissueshaper 4.

The second tissue displacing element 8 may then be used to engagestomach tissue in the central portion of the tissue shaper 4 as shown inFIG. 29. The tissue is then pulled down by the second tissue displacingelement 8 and fasteners 3, 4, 5 may then be applied simultaneously ormay be applied one at a time between manipulations of the second tissuedisplacing element 8. When moving the first and third tissue displacingelements 6, 10, the lock 75 may be used to lock the first and thirdtissue displacing elements together 6, 10 and simultaneously move thefirst and third tissue displacing elements 6, 10.

In another example of the present invention, fasteners 3, 4, 5 along themiddle of the tissue shaper 4 (and along the middle of the tissue foldbeing created) are applied first and tissue is then manipulated prior toapplication of fasteners 1,2 and 6, 7 at the ends 24, 26 of the tissueshaper 4. Tissue may be manipulated between fastening steps by engagingtissue with the first and third tissue displacing elements 6, 10 and/ortissue shifting element 110 to tighten or loosen the fold, to lengthenthe ends of the fold or to longitudinally stretch the fold as deemednecessary and as described herein. For example, the second tissuedisplacing element 8 is used to displace the central portion of thetissue fold downward and the first and third tissue displacing elements6, 10 may then be engaged with tissue as shown in FIG. 30. The first andthird tissue displacing elements 6, 10 are then retracted to pull tissuedownward and also to move tissue towards the ends of the tissue shaper4. To this end, the tissue displacing elements 6, 10 may impartdisplacements in any manner described herein. For example, the first andthird tissue displacing elements 6, 10 may pull tissue towards the ends24, 26 of the mold followed by displacement within the slots 4 towardthe ends 24, 26 in a manner similar to the displacements shown in FIGS.26-28 but in the opposite direction. In this manner, the tissue fold iscreated from the central portion towards the ends 24, 26 of the tissueshaper 4.

In yet another method of applying the fasteners F1-F7, the fastenerapplier may be held in a substantially stationary position and thetissue is manipulated after each fastener application. Referring againto FIGS. 22 and 23, an example of such a method is shown. Fastener F3 isapplied in the position of FIG. 22. The tissue is then pulled furtherinto the tissue shaper 4 using the tissue displacing elements 6, 8, 10(or the common retractor to displace all three tissue displacingelements 6, 8, 10 simultaneously) and fastener F4 is then appliedwithout moving the fastener applier from the position in which fastenerF3 was applied. In this manner, the fastener applier may stay in asingle, stationary position for several fastening steps while the tissueis manipulated between fastening steps. Fastener F5 may then be appliedafter further displacement of tissue to complete a row of fasteners nearthe central plane. Rather than completing the row of fasteners, the usermay rotate the fastener applier to apply fasteners F1 and/or F6.

Referring now to FIG. 31, the tissue may also be manipulated through theopen end 65 of the tissue shaper 4 and all methods described above maybe practiced in this manner. For example, the method of applying thefasteners F1-F7 just described may be useful when the fold of tissueextends through the open end 65 of the tissue shaper 4. The user mayclearly see how the formation of the fold is progressing as eachfastener F1-F7 is applied and the fold becomes exposed through the openend 65 of the tissue shaper 4. As such, all methods of manipulating andfastening tissue described herein shall be applicable to methods ofgathering and fastening tissue which partially extends through the openend 65 of the tissue shaper 4.

Referring to FIGS. 35-37, another device 202 is shown for displacing andfastening tissue wherein the same or similar reference numbers refer tothe same or similar structure of FIGS. 1-34 with the difference beingthe orientation of a tissue shaper 204. All methods, uses andcharacteristics of the devices of FIG. 1-34 are applicable andincorporated here for device 202 with the designations proximal anddistal being substituted for one another as necessary for theorientation of the tissue shaper 204. For example, the tissue displacingelements 206, 208, 210 of FIG. 35 may change radial orientation,displace tissue, and/or shift tissue within the tissue shaper 204 in anymanner described with reference to FIGS. 1-34. Furthermore, the tissueshaper 204 of FIG. 35 (simplified for clarity) may be any of the tissueshapers described herein and all substitutions are hereby expresslyincorporated. For example, the tissue shaper 4C of FIG. 34 may be usedwith the device 202 so that the first and second clamping elements 61B,63B may be used to clamp tissue.

The tissue shaper 204 is oriented in the opposite direction from thetissue shapers of FIGS. 1-34 in that an open end 201 through whichtissue is drawn is at a distal end rather than the proximal end of thetissue shaper 204. The tissue shaper 204 may be used anywhere in thestomach or esophagus but may be well suited to form tissue folds alongthe lesser curvature of the stomach at junction JN to the esophagealtract. Such a procedure may help treat GERD by bolstering, reinforcing,and/or tightening the area around the junction between the stomach andesophageal tract. Forming folds along this location may be conducted inassociation with procedures that create folds as described herein or thedevice itself may be used to form folds along the greater curvature sideof the junction in the manner described herein. The tissue structurescreated along the lesser curvature side may be intended to interact withstructures, such as a native or reconstructed flap, on the greatercurvature side.

In one aspect, the tissue shaper 204 is positioned in the esophagus andstomach tissue is drawn into the tissue shaper with one or more of thetissue displacing elements 206, 208, 210 in any manner described inrelation to FIGS. 1-34 which are incorporated here. For example, thetissue displacing elements 206, 208, 210 may be displaced stepwise,independently or simultaneously. After application of one or morefasteners, the resulting fold is released and falls back into thestomach so that part of fold opposes the flap on the greater curvatureside. In one aspect of the invention, the fold is fastened on the lessercurvature side at least 1 cm, and may be at least 3 cm, above thejunction between the esophageal tract and the stomach on the greatercurvature side. Stated another way, the fold is formed within theesophagus so that when the fold is released the fold is positionedopposite a distal portion of the junction on the greater curvature side.

The tissue shaper 204 may be oriented so that a convex side CV of thefold is oriented radially inward (faces inward) relative to theesophagus. The convex shape may be naturally created by a convex shapeTCS of the tissue shaper 204 when fasteners are applied as describedabove. Orienting the fold with the convex side TCS of the tissue shaper204 facing inward may help displace the lesser curvature side closer tothe greater curvature side thereby potentially improving the seal. Ofcourse, the fold may be created in a conventional fashion with theconvex side facing radially outward by rotating the device 180 degrees.

Referring to FIGS. 38-44, another device 300 for manipulating andfastening tissue is shown. The device 300 includes an elongate body 302having a tissue grasper 304 with vacuum orifices 306 to grasp tissuealong an outer surface 308 of the body 2. The tissue grasper 304 isdescribed in greater detail below. A tissue shaper 308 has a shaft 309that passes through a lumen 310 (see FIG. 43) in the tissue grasper 304.The shaft 309 of the tissue shaper 308 is aligned with the longitudinalaxis LA of the tissue grasper and extends longitudinally from the tissuegrasper so that the tissue grasper 304 and the tissue shaper 308 may berotated relative to one another about a longitudinal axis LA (defined bythe elongate body 302) and longitudinally translated as well. Themodular design of the tissue grasper 304 and tissue shaper 308 allow anyof the tissue shapers described herein to be used with any of the tissuegraspers described herein and all combinations are expresslyincorporated as can be appreciated by one of ordinary skill in the art.

The tissue shaper 308 has a mold 310 that is pivotally coupled to theshaft 309 at hinge 311. In this manner, the mold 310 also pivotsrelative to the elongate body 302 and the tissue grasper 304. Tissue isdrawn into the mold 310 using a tissue displacing element 312 (not shownfor clarity in other figures) having a helical coil 314 mounted to awire 316 similar to those described above and incorporated here. Thetissue shaper 308 forms a cavity 317 between the mold 310 and the shaft309. The tissue shaper 308 may shape tissue in any other mannerincluding a relatively static structure or a pair of jaws withoutdeparting from numerous aspects of the present invention. The mold 310may pivot relative to the body 302 in any suitable manner such as thosedescribed in US Patent App. Nos. 2006/0116697, 2010/0222788,2002/0082621, 2004/0138529 and 2011/0087198 which are incorporatedhereby incorporated by reference. The mold 310, together with the tissuedisplacing element 312, the tissue grasper 304, and other mechanisms,work together to shape tissue into a desired shape in accordance withmethods described below.

The tissue shaper 308 has a fastener guide 313 which may receive andguide a fastener 315 (see FIG. 47B), or other suitable fastener such asthose described in U.S. Pat. No. 8,337,523 incorporated here byreference. The fastener 315, which may be used with all methods andtissue shapers of the present invention, is delivered on a stylet 321and through a cannula 323 as shown in FIG. 47B. The fastener 315 has afirst leg 327 mounted to the stylet 321. The first leg 327 has anelongate opening 325 and another elongate opening 333 for releasing thefirst leg 32. A second leg 329 trails the first leg 327 within thecannula 323. Of course, any other fastener may be used with the presentinvention without departing from the scope of the invention includingstaples, suture, a shaped implant and/or adhesive. Furthermore, thefasteners may be provided in a cassette or may be pre-loaded in thedevice.

The tissue shaper 308 also includes a first tissue shifting element 318to shift tissue within the tissue shaper 308 on a radially inner side320 (adjacent the elongate body) and a second tissue shifting element322 to shift tissue on a radially outer side 324 (adjacent the pivotingmold). The first and second tissue shifting elements 318, 322 may beformed like a paddle 323 having integrally formed barbs 325 cut andformed from a plate of material but may also be a series of independenthooks, a helical coil or any other suitable structure. The second tissueshifting element 322 may include a space or slot therein (not shown) toreceive the tissue displacing element 312 (see FIG. 38).

The first and second tissue shifting elements 318, 322 are mounted onrails 323 that guide movement of the elements 318, 322. The rails 323also bias the first and second tissue shifting elements 318, 322 to theposition of FIG. 40. To this end, one or both of the rails 323 may besomewhat skewed so that the rails 323 diverge. Referring to FIG. 39, anactuating wire 325 moves the second tissue shifting element 322 to theposition of FIG. 41. Doing so causes the rails 323 to spread apartsomewhat. After shifting tissue, tension on the wire 325 is released sothat the rails 323 are free to spread apart and move the first andsecond tissue shifting elements 318, 322 back to the position of FIG.40.

The first and second tissue shifting elements 318, 322 may beindependently operated or may be coordinated to displace tissue at thesame time as shown in FIG. 41. The first and second tissue shiftingelements are 318, 322 are relatively large compared to the tissue shaper308 and may have a maximum lateral dimension LD which is at least 75% ofa maximum lateral dimension of the mold MLD with the lateral dimensionbeing measured in a direction transverse to the longitudinal axis LA andtransverse to an axis of motion AM of the tissue shifting elements 318,322.

When operating the tissue shifting elements 318, 322, the mold 310 ispartially closed (compared to a fully closed position for fastening andmanipulating tissue) so that the tissue layers are approximated andmoderately compressed. The graphical depiction of FIG. 40 shows thelayers separated for clarity and the jaws opened slightly larger thanthe partially closed condition. In this manner, the first and secondtissue shifting elements 318, 322 are pressed into engagement withtissue while the tissue is held loosely enough to permit the tissue toslip further in the mold 310. The first and/or second tissue shiftingelements 318, 322 are then moved to shift tissue further into the tissueshaper 304 thereby lengthening the fold.

The first and/or second tissue shifting elements 318, 322 may be usedwith all methods of the present invention to move tissue into the tissueshaper 308 prior to fastening even when not expressly mentioned with aparticular method. The tissue grasper 304, or any of the other suitabletissue graspers described herein, may also be used to move tissue intothe tissue shaper by moving the tissue grasper and tissue shaper towardone another (moving one or both). Similarly, in all methods of thepresent invention, even when not mentioned, any of the tissue graspersand tissue shapers may be moved together longitudinally to move moretissue into the mold and lengthen the fold. Finally, the terms “spreadapart” or “moved together” as used herein refers to relative motion bymoving one or both sides. When moving both sides, the sides may be movedindependently (in either order or stepwise) or simultaneously. Use ofthe tissue grasper 304 and tissue shaper 308 is described below inconnection with methods of the present invention.

Referring now to FIGS. 42-44, the tissue grasper 304 is now described.The vacuum orifices 306 on the outer surface 308 of the elongate body302 adhere tissue to the body 2. The suction orifices 306 form acircumferential sealing surface 299 that forms a circumferential sealwith tissue adjacent the elongate body 302 when suction is activated. Arecess 330 extends from the vacuum orifice 306 in the outer surface 308.An o-ring 309 forms a seal around the tissue shaper 308 (removed fromFIG. 43 for clarity). The vacuum orifices 306 may be round, oval, or anyother suitable shape including an elongate slot 332 as shown. The shapemay also be a compound shape such as a round opening superimposed on theslot 332.

Referring to FIGS. 43 and 44, a cross-sectional view of the slot 332 isshown. The tissue grasper 304 may have a tissue piercing element 334 ineach recess 330 movable from the stored position of FIG. 43 to theworking position of FIG. 44. The tissue piercing element 334 has a sharptip 336 that preferably does not extend far out of the recess 330 whenengaging tissue in the working position so that the piercing element 334is less likely to harm tissue adjacent the target tissue. In a specificaspect, the tissue piercing element 334, and specifically the sharp tip336, extends no more than 4 mm from the outer surface 308 of the body302 in the working position and is positioned at or below the outersurface 308 in the stored position. The outer surface 308 of the body302 is generally defined by the shape of the body 302, such as generallycylindrical and, thus, positioning the tissue piercing element 334 inthe recess 330 shall be considered below the outer surface 308 eventhrough the slot 332 is open.

The tissue piercing elements 334 are driven by an actuator 336 which maybe a round collar 338 that simultaneously actuates all of the tissuepiercing elements 334. The actuator 336 is advanced from the position ofFIG. 43 to the position of FIG. 44 so that a first cam surface 340 onthe collar 338 slides against a second cam surface 342 on the tissuepiercing element 334 thereby moving the element 334 out of the recess topierce tissue. The elongate slot 332 may help maintain alignment andorientation of the piercing element 334 as the piercing element 334 isdeployed since the tissue piercing element slides against and is guidedby sidewalls 338 of the slot 332. An advantage of providing the recess330, such as the elongate slot 332, with the tissue piercing element 334being advanced out of the recess 330 is that the use of suction prior toadvancing the tissue piercing element 334 may help ensure that thetissue piercing element 334 engages a modest amount of tissue whilelimiting the extent that the piercing element 334 extends from the outersurface 308 of the body 302 to prevent damaging adjacent structures.

The tissue piercing element 334 may be generally directed in a distaldirection so that the tissue piercing elements securely support distaldisplacement and rotation of the tissue grasper 304. Of course, anyorientation may be used, such as radial or even extending generallyproximally, without departing from the scope of the invention. Thepiercing element 334 has a fixed end 340, however, the piercing element334 may also be pinned, captured by an elastic element or even capturedwithout attachment, such as a block or pin movable within a groove.Furthermore, the piercing element 334 may be actuated in any suitablemanner, such as pneumatic, a pull wire, or use of suction, withoutdeparting from the scope of the invention.

Referring to FIGS. 45-47, another device 350 for grasping, displacingand fastening tissue is shown which includes a first tissue shaper 352having a first shaft 353 and a second tissue shaper 354 having a secondshaft 355 both extending through an elongate body 356 of a tissuegrasper 357. The tissue grasper 357 may be any of the tissue graspersdescribed herein for adhering tissue to the elongate body 356 asdescribed below in connection with various methods of the presentinvention. The second shaft 355 extends through the first tissue shaper352 so that the first and second tissue shapers 352, 354 arelongitudinally translatable and rotatable relative to one another abouta longitudinal axis LA. The longitudinal axis LA is generally defined bythe shape of the elongate body 356 and it is understood that theelongate body 356 may be flexible and/or curved while still generallydefining the longitudinal axis LA in all aspects of the presentinvention and for all embodiments described herein.

The first tissue shaper 352 has a first mold 358 pivotally coupled tothe elongate body 356 and the second tissue shaper 354 has a second mold360 which also pivots (and rotates) relative to the body 356. The firstand second molds 358, 360 may be formed and actuated in any suitablemanner as is known to those of ordinary skill in the art with each mold358, 360 pivoting between the closed and fully extended positions ofFIG. 47. Suitable mechanisms are well known in the art and include thosedescribed in the patent applications incorporated above. The first andsecond molds 358, 360 are pivotally coupled to the first and secondshafts 353, 355 at distal ends 359, 361 of the shafts 353, 355. Thefirst and second molds 358, 360 each pivot about an axis PV that istransverse to the longitudinal axis LA. The first tissue shaper 352forms a first cavity 367 (into which stomach tissue is drawn using thefirst tissue displacing element 362) and the second tissue shaper 354forms a second cavity 369 (into which stomach tissue is drawn using thesecond tissue displacing element 364). The first cavity 367 is formedbetween the first mold 358 and the first shaft 353 and the second cavityis formed between the second mold 360 and the first shaft 353.

The first tissue shaper 352 has a first tissue displacing element 362,such as a wire 363 and a helical coil 364, and the second tissue shaper354 has a second tissue displacing element 364 each configured to drawtissue into the respective tissue shaper 352, 354. The tissue displacingelements 362, 364 may be initially guided by the molds 358, 360 and maybe subsequently released as tissue is drawn into the respective tissueshaper 352, 354. The first tissue shaper 352 includes a first fastenerguide 366 which guides fasteners, such as the fastener 315 of FIG. 47B,through tissue positioned in the first tissue shaper 362. A secondfastener guide 368 is also coupled to the first tissue shaper 352 anddelivers fasteners 315 to tissue held by the second tissue shaper 354.The second tissue shaper 354 aligns with the second fastener guide 368at a fixed angular orientation relative to the first tissue shaper 352,such as 90 degrees, when fasteners 315 are applied to tissue in thesecond tissue shaper 354. Of course, the second tissue shaper 364 mayalso have a fastener lumen that rotates with the second tissue shaper354 rather than the first tissue shaper 352. Alternatively, the secondtissue shaper 354 may not include a fastener lumen or guide and allfasteners may be applied by the first tissue shaper 352 with the secondtissue shaper 354 used to anchor, stretch and manipulate the tissue foldas described below. Use of the device 350 is described below inconjunction with methods of the present invention.

Referring to FIG. 48, another tissue grasper 380 and tissue shaper 381are shown. The tissue shaper 381 may be any of the tissue shapersdescribed herein and the tissue shaper 381 has a single pivoting mold383 for clarity. The tissue grasper 380 has a number of vacuum orifices382 on the outer surface 381 of an elongate body 383 that defines alongitudinal axis LA. The vacuum orifices 382 adhere the elongate body383 to the esophagus (or to stomach tissue previously manipulated asdescribed herein). The tissue shaper 381 extends through a lumen 371 inthe tissue grasper 380 so that the tissue shaper 381 is rotatable aboutthe longitudinal axis LA and longitudinally translatable relative to thetissue grasper 380 for use as described below.

The tissue grasper 380 is divided into a number of sections. The tissuegrasper 380 has a first section 386 and a second section 388 which maybe independently activated and are separated at boundary 390. The firstsection 386 extends 270 degrees around the body 383 while the secondsection extends 90 degrees when viewed along the longitudinal axis LA.Together, the first and second sections 386, 388 provide a fullcircumferential sealing surface that adheres and seal with the esophagusfor inflating and deflating the stomach as necessary and formanipulating the esophagus.

The tissue grasper 380 also includes a third section 392 and a fourthsection 394 (hidden in FIG. 48) which are independently rotatable aboutthe longitudinal axis and longitudinally translatable relative to oneanother, to the tissue shaper 384, and to the first and second sections386, 388 as shown by the diagram of FIG. 49. Referring to thecross-sectional view of FIG. 50, the third section 392, like the fourthsection 394, may initially adhere to tissue with suction at the vacuumorifice 382 which leads to a recess 396. A tissue piercing element 398having a sharp tip 397 is positioned in the recess 396 at or below theouter surface 381 when in the stored position similar to the tissuegrasper of FIGS. 42-44. Furthermore, the recess 396 may be a slot 399having sidewalls 401 that support movement of the tissue piercingelement 398. The tissue piercing element 398 is moved to the workingposition by an actuator 400 having a pull wire 402 coupled to a wedge404 that applies a force to move the tissue piercing element to a biasedposition. The sidewalls 401 of the slot 399 also support movement thewedge 404. The wedge 404 may be advanced for shallow penetration, suchextending no more than 4 mm from the outer surface, when adjacentstructures are potentially problematic and deeper penetration when nosuch structures are present and/or when full thickness control of atissue layer is desired. The tissue piercing element 398 naturally movesback to the stored position and displaces the wedge 404 when tension isreleased on the pull wire 402.

In one aspect of the invention, the third and fourth sections 392, 394may be positioned at the same longitudinal position relative to theelongate body 383 for manipulating tissue therebetween. For example, thethird and fourth sections 392, 394 may be used to hold the site of aprior applied fastener, the end of the fold, or an intended fastenersite among other uses. The third and fourth sections 392, 392 may alsobe positioned at the same longitudinal position to form a window 405that may be positioned at a fastener application site 407 with thewindow 405 forming a gap between the third and fourth sections 392, 394.The third and fourth sections 392, 394, like the second section 388, mayalso act on a limited, defined portion of tissue and, as such, mayextend less than 100 degrees around the body when viewed along thelongitudinal axis.

The sections of the tissue grasper 380 which are not activated shallconstitute a free section 399 that is free of attachments to tissue. Assuch, the tissue adjacent the free section is free to stretch or gatherin accordance with methods described below. Thus, when the first section386 is activated and the second section 388 is not, the second section388 shall constitute the free section of the tissue grasper so that thefree section extends about 90 degrees when viewed along the longitudinalaxis. Stated another way, the tissue adjacent non-activated or freesections of the tissue grasper 380 are free of attachment and free todisplace relative to the tissue grasper 380 even though another part ofthe tissue at the same longitudinal position is held by the tissuegrasper. In one specific method described below, for example, the freesection 399 is positioned between a previously applied fastener and thenext intended fastener location. Finally, when the tissue grasper 380,or other tissue graspers described herein, is spread apart from anotherelement or moved relative to another element, only the active parts ofthe tissue grasper 380 shall be considered. For example, the tissuegrasper 380 may have only the third section 392 activated to adhere totissue so that reference to position or reference to relative motion ofthe tissue grasper 380 shall be as to the third section 392 only.

The tissue graspers of the present invention are relatively simplestructures which can be formed along the outer surface of the elongatebodies shown herein without excessive intrusion as can be encounteredwhen a number of tools are used in the stomach as suggested by someapproaches. Some prior art solutions suggest the use of numerousindependent grasping jaws each having an independent shaft and pair ofjaws operated within the stomach. In an aspect of the present invention,the tissue graspers are positioned on the outer surface of the elongatebody which may be generally cylindrical. As such, the tissue graspers ofthe present invention provide the ability to manipulate tissue withoutrequiring numerous instruments, and in particular numerous grasping jawshaving independent shafts, extending into the stomach although aspectsof the present invention, such as the following aspects related toreinforcing, may be practiced with any device include those withmultiple grasping jaws having independent shafts.

Referring to FIGS. 51, 52, 53A, 53B, 54A and 54B, a reinforcing element410 is shown to reinforce the stomach and folds formed in the stomachsuch as at anterior and posterior ends of the fold. The series of foldsformed around the devices of the present invention typically do notextend fully around the esophagus and typically extend from 180 degreesto 270 degrees relative to the longitudinal axis of the elongate body(although more or less may be encountered, of course). As such, thepattern of fasteners (as discussed further below) created at an upperend of the series of folds may be characterized as C-shaped, U-shaped orhorseshoe shaped at times.

The reinforcing element 410 is positioned to couple the posterior andanterior ends of the fold together. The reinforcing element 410 has afirst side 413 and a second side 419 with each side being positionedadjacent an end of the fold. The reinforcing element 410 may include afirst eyelet 412 sized and configured to receive a first fastener 315and a second eyelet 414 sized and configured to receive a secondfastener 315. In one aspect, the first and second sides 413, 419 arepositioned on opposite sides of a boundary between the anterior andposterior sides. In this manner, the ends of the fold are anchored toeach other thereby reducing slipping and distension. The reinforcingelement 410 also may help to reduce the overall load on fasteners at theends of the fold by absorbing some of the load that would otherwise beapplied to the fasteners. Furthermore, the reinforcing element 410 mayhelp create a more “rounded” shape that may distribute loads more evenlythan C, U or horseshoe shaped patterns.

The reinforcing element 410 may include a polymer sheet 416 and a wovenelement 418 that reinforces the polymer 416. A raised lip 420 extendsaround the periphery of the reinforcing element 410 to help thereinforcing element 410 maintain shape although the reinforcing element410 is preferably relatively flexible to conform to the stomach asnecessary. The reinforcing element 410 may also simply include the wovenelement 418 with the fastener being driven through interstitial spaces422 of the woven element 418. The reinforcing element 410 may also omitthe eyelets 412, 414 with the fastener being driven directly through andpenetrating the polymer sheet 416 during fastening. Fasteners may alsobe driven through the reinforcing element 410 between the eyelets 412,414 to pierce the polymer sheet 416 and drive the fastener through theinterstitial space 422 of the woven element 418.

Referring to FIGS. 53A and 53B, the reinforcing element 410 may bemounted to a tissue grasper 424 which may be any of the other tissuegraspers described herein and all such combinations are expresslyincorporated. A tissue shaper 425, which also may be any of the tissueshapers described herein, has a pivoting mold 427 coupled to a shaft429. The shaft 429 extends through the tissue grasper 424 so that thetissue shaper 425 may be rotated and translated relative to the tissuegrasper 424. The tissue shaper 425 also includes the tissue displacingelement (as shown in FIG. 38) which is retracted and not visible in FIG.53. The reinforcing element 410 may also be delivered on a separatedelivery element from the tissue grasper 424 or may be mounted to thetissue shaper 425 without departing from numerous aspects of theinvention.

A support collar 426 extends distally from the tissue grasper 424 andthe reinforcing element 410 is positioned in a complementary shapedcavity 428 in the collar 426. The collar 426 also has openings 428 thatalign with the eyelets 412, 414 to guide the fastener through theeyelets 412, 414. The tissue grasper 424 and tissue shaper 425 arepositioned in a fixed radial orientation to align the eyelets 412 with afastener delivery guide 415. The collar 42 supports the reinforcingelement 410 to expose the first and second sides 413, 419 (andspecifically the first and second eyelets 412, 414) for application of afastener. Since the tissue grasper 424 is used for delivering thereinforcing element 410, the tissue grasper 424 at times may constitutea delivery device 421 for the reinforcing element 410 but may includeall features of the tissue grasper 424.

The tissue grasper 424 includes a first section 430, a second section432 and a third section 434 similar to the tissue grasper of FIGS. 48and 49. The first section extends 270 degrees while the second sectionextends 90 degrees relative to longitudinal axis LA. The support collar426 may be centered on the second section 423 or the third section 434.The collar 426 supports the reinforcing element 410 while exposing thefirst and second sides 413, 419 for application of a fastener throughthe eyelets 412, 414.

The third section 434 is substantially the same as the tissue grasper ofFIGS. 42-44 described above but extends only 90 degrees relative to thelongitudinal axis LA. Referring to the cross-sectional views of FIGS.54A and 54B, the third section 434 includes vacuum orifices 436 and arecess 438, such as an elongate slot 440 having sidewalls 442, and mayinclude a tissue piercing element 444 positioned in each recess 438. Anactuator 446 is used to move the tissue piercing element 444 in the samemanner as the tissue grasper of FIGS. 42 and 43 described above and allaspects are incorporated here. The actuator 446 may also be used torelease the reinforcing element 410 with further advancement of theactuator 446. The reinforcing element 410 is anchored to the supportcollar 426 with a suture 448 extending through the eyelets 412, 414 (orany other suitable part of the reinforcing element 410 such as throughthe woven material 418). The suture 448 extends through the collar 426and is exposed in a trough 450. The actuator 444 has a tip 452 whichextends into the trough 450 to sever the suture 448 thereby releasingthe reinforcing element 410 as shown in FIG. 54B. A lock (not shown) maybe provided to prevent inadvertent advancement of the actuator 446 andaccidental release of the reinforcing element 410.

The ends of the fold may be anchored by positioning the second section432 and/or the third section 434 adjacent one or both ends of the fold.In one method of deploying the reinforcing element 410, one side (orboth sides) of the reinforcing element 410 is fastened to tissuesimultaneous with formation of a fold. After fastening the reinforcingelement 410 to stomach tissue, the reinforcing element 410 continues tobe held by the tissue grasper 424 with the suture 448 and, as such,forms part of the tissue grasper 424 for rotating, stabilizing and/orotherwise manipulating tissue as desired. The reinforcing element 410may also be fastened to tissue independent of forming a fold asdiscussed further below.

As mentioned above, the reinforcing element 410 may be used to securethe anterior and posterior ends of the fold together. Stated anotherway, the reinforcing element reinforces an area between adjacent foldsand, specifically, may extend across the boundary between the anteriorand posterior sides of the stomach along the lesser curvature side ofthe stomach and may be fastened on both the anterior and posteriorsides.

In another aspect of using the reinforcing element 410, the final stepin securing the reinforcing element 410 may be performed after formingall of the folds or concurrently with formation of the final fold. Inthis manner, the reinforcing element 410 may be positioned and tensionedas desired to relieve loads on previously placed fasteners. Statedanother way, folds may be formed to create a partial circumferentialpattern with the reinforcing element 410 bridging the gap in the partialcircumferential pattern to form a complete circumferential pattern. Thegap may be bridged with the reinforcing element 410 secured across theboundary between the anterior and posterior sides. Alternatively, thereinforcing element 410 may also be applied at areas other than the endsof the fold where high forces and/or stomach expansion is expected asdescribed below.

The term pattern of fasteners as used herein shall be defined as thepattern created by those fasteners that communicate with adjacentfasteners to resist local deformation of the pattern. The posterior andanterior ends of the C, U or horseshoe shaped fastener pattern describedherein are partial, rather than fully circumferential, since theanterior and posterior ends of the fold do not together resist localdeformation of the pattern. Loads on the fastener at one end are notshared by the fastener at the other end due to physical constraints ofthe stomach in this region. The physical constraints in this region alsolimit the ability to form a fold that prevents creating a fullcircumferential pattern.

Referring now to FIGS. 46, 47 and 53, the tissue grasper 424 of FIG. 53(together with the reinforcing element 410) may be substitute for thetissue grasper 357 for use with the first and second tissue shapers 352,354 of FIGS. 47 and 48 for use as now described. The second tissueshaper 354 is aligned with one of the two eyelets 412, 414 andpositioned at an end of the fold (anterior or posterior). The secondtissue shaper 354 then applies a fastener through one of the eyelets412. The first tissue shaper 352 is then positioned near the nextintended fastener site. Stomach tissue is then drawn into the firsttissue shaper 352 using the first tissue displacing element 362. Thefirst tissue shaper 352 and the reinforcing element 410 are then spreadapart prior to fastening with the end of the fold held by thereinforcing element 410 and the tissue grasper. Alternatively, the firsttissue shaper 352 and the reinforcing element 410 may also be movedtogether (rather than spread apart) depending on the particular anatomyand desired direction of wrap. The other end of the reinforcing element410 may also be attached in a similar manner to complete thecircumferential pattern across the anterior/posterior boundary asdescribed above with or without formation of a fold.

Use of the devices described above and further methods of the presentinvention are now described. For the purpose of illustrating the presentinvention, FIG. 55 is a simplified diagram of one application of thepresent invention, namely, forming a series of folds to create thejunction between the esophageal tract and the stomach using stomachtissue. Various related methods and devices are described in U.S. Pat.No. 7,942,887 that is hereby incorporated by reference. Each fastenerF1-F7 is applied to create a fold with the folds being formedcontinuously with one another. Each fold is created by using one of thetissue displacing elements disclosed herein to draw tissue toward andinto one of the tissue shapers described herein followed by applicationof a fastener to hold the fold. The reinforcing element 410 is depictedbetween fasteners F1 and F2 for use as described above and incorporatedhere for all methods. Although fasteners F2 and F1 are shown deployed,they may be deployed later (such as last in the fastener pattern) or inany other suitable manner. The reinforcing element 410 is also shown indotted line separated from the fasteners that form the folds torepresent attachment of the reinforcing element 410 independent ofcreating a fold.

The folds may be formed continuously with previously formed folds sothat a combined fold progress around the device. Fasteners F1-F7 may beplaced in any order and the particular order described is only for thepurpose of illustration. Furthermore, more (or fewer) fasteners may beused in varying patterns also without departing from the presentinvention.

Referring to FIG. 56, a graphical depiction of the combined foldprogressing with fasteners F1-F4 previously applied to form two separatefolds progressing from the anterior and posterior ends. Methods inaccordance with the present invention are now described with referenceto application of fastener F5 and formation of the fold at F5. Use of atissue shaper TS, which may be any of the tissue shapers describedherein, and a tissue grasper TG, which also may also be any of thetissue graspers described herein, is described. The orientation ofvarious devices, elements and aspects of the present invention aretypically described with reference to viewing along the longitudinalaxis and, as such, refer to angular orientations relative to thelongitudinal axis. Thus, when it is stated that a prior placed fastener(such as F4) is positioned between the tissue shaper TS and the tissuegrasper TG the position refers to the angular orientation when viewedalong the longitudinal axis. As such, the tissue shaper TS and tissuegrasper TG may be spread apart (or moved together) in accordance withthe present invention by rotating one or both even though the tissueshaper TS and tissue grasper TG act at different longitudinal positionsso long as the intended relative motion is imparted and results in thetissue being spread apart (or moved together). Finally, when describingmotion of the tissue shaper TS, the tissue shaper TS may hold tissuewith the tissue engaging element, the mold, or both.

In one aspect of the present invention, the tissue grasper TG and tissueshaper TS may be spread apart to tighten the fold and wrap the foldaround the body of the tissue grasper TG and the shaft of the tissueshaper TS to create a desirable shape. The tissue shaper TS and tissuegrasper TG may be spread apart in any manner by rotating one or both(independently, in either order, or simultaneously). When the tissuegrasper 380 of FIG. 48 is used, one section, such as the second section388, may be activated while the other side (such as the first section386) is not so that the non-activated section constitutes the freesection 399. The second section 388 may be positioned relative to thetissue shaper TS to preferentially tighten a specific location orregion. For example, the second section 388 may be placed so that thefree section 399 of the tissue grasper 380 is positioned between theprior placed fastener F4 and the tissue shaper TS so that this tissue isfree to displace and stretch (or be gathered) as desired in this region.The second section 388 may, of course, be placed closer to other priorplaced fasteners, such as near F2, to tighten and stretch a largerregion. In this manner, the tissue shaper TS is spread apart from theprior placed fastener F4 on one side while the tissue grasper TG isspread apart from the prior placed fastener on the other side (whenviewed along the longitudinal axis). In this manner, the tissue iswrapped, tightened and/or shaped as desired. If the tissue grasper 380is used, the third section 392 (or the fourth section 394) may also beused to control tissue. For example, the third section 392 may bepositioned to hold the prior placed fastener F4 to spread apart thetissue shaper TS from the prior placed fastener F4.

As mentioned above, the tissue grasper TG and tissue shaper TS may alsobe moved toward one another longitudinally to move tissue into thetissue shaper TS before fastening. Moving the tissue grasper TG andtissue shaper TS toward one another may be performed before applying thefastener in all methods of the present invention whether or notexpressly described. Furthermore, the tissue shifting element of FIGS.39-41 may also be incorporated into any of tissue shapers TS, and inparticular any pivoting mold described herein to further shift tissueinto the tissue shaper TS also in connection with all methods describedherein prior to fastening.

Referring to FIG. 57, another method is depicted in connection with thedevice having the first and second tissue shapers 352, 354 of FIGS.45-47 used with the tissue grasper 380 of FIGS. 48-50. Tissue is drawninto the first tissue shaper 352 using the first tissue displacingelement 362. The second tissue shaper 354 holds the previously formedfold at F4 and the first and second tissue shapers 352, 354 are thenspread apart. To this end, the second tissue shaper 354 may hold theprior formed fold at a control location 460, such as near F4, to locallytighten the fold between F4 and F5 or nearer to F1 to tighten the entireprior formed fold. The control location 460 is positioned between thefirst tissue shaper 352 and the end of the fold (at F1). The firsttissue shaper 352 is preferably rotated away from the second tissueshaper 354 to tighten and wrap the fold and to create the desiredgeometry. Any one of the first, second, third or fourth sections of thetissue grasper 350 may also be positioned to be spread apart from thesecond tissue shaper thereby wrapping and tightening the fold on bothsides of the second tissue shaper 354. For example, the third section392 is shown at the end of the fold, the fourth section 394 graspingtissue at the prior fastener F4 and the second section 386 positionedacross the anterior/posterior boundary and grasping both the anteriorand posterior ends of the fold.

Still referring to FIG. 57, another method is now described. The tissueshaper 352 is used to displace tissue and form the fold in anticipationof fastening at F5. The control location 460 lies between the tissueshaper TS and the end of the fold and may be positioned at the priorfastener F4. The control location 460 may also be controlled by thethird section 392 of the tissue grasper 380 (rather than the secondtissue shaper 354 as described above). The reinforcing element 410and/or the fourth section 394 of the tissue grasper 380 may be placednear the end of the fold to spread apart more of the previously formedfold. In this manner, the fold is controlled at numerous locations; theleading edge of the fold, the end of the fold and a control locationintermediate of the leading edge and end. An advantage of this method isthat the tissue can be controlled with the first, second, third andfourth sections which may provide advantages over more complex systemshaving multiple jaws.

In still another method of using the first and second tissue shapers352, 354 with the tissue grasper 380 of FIGS. 48-50, the second tissueshaper 354 may be used to form a fold ahead of the anticipated fasteningsite for the first tissue shaper 352 at F5 or, stated another way, thefold is fastened at an intermediate position of fold progression asshown in FIG. 58 rather than at the leading edge. The first tissueshaper 352 may initially form a fold in preparation for application offastener F5. The second tissue shaper 354 is then used to continueformation of the fold prior to application of fastener F5. By displacingtissue with the second tissue displacing element 364 ahead of the firsttissue shaper 352, the load on fastener F5 may be reduced somewhatbefore fastening. This procedure may be preferable when high forces areencountered and/or expected due to likely stomach expansion.

The first and second tissue shapers 352, 354 may also be spread apart tofurther tighten the tissue around the intended fastener site F5 beforeapplying fastener F5. At this time, the first mold 358 may be open orpartially open to permit the tissue to slip somewhat within the firstmold 358 while the first tissue displacing element 362 continues tosecurely hold the tissue in the first tissue shaper 352. The secondtissue shaper 354 may continue to hold the tissue after application offastener F5 and may apply fastener F7 without releasing the tissue sothat relief of loads at F5 is maintained. Fastener F7 is applied bymoving the first tissue shaper 352 to align the second fastener guide368 with the second tissue shaper 354 and fastener F7 may be appliedwith the second tissue shaper 354. Alternatively, the first tissueshaper 352 may simply be moved adjacent the second tissue shaper 352 toapply fastener F7 without releasing the tissue held by the second tissueshaper 354. Any one of the first, second, third and fourth sections 386,388, 392, 394 of the tissue grasper 380 may also be used to tighten andwrap tissue. For example, the third section 392 is positioned may bespread apart from the first tissue shaper 352 on one side while thesecond tissue shaper 354 is spread apart from the first tissue shaper352 on the other side. The above described method may then be repeatedby rotating the first tissue shaper 352 past the second tissue shaper354 and repeating.

Still another method of the present invention is now described. Uponcompletion of all folds, the stomach may tend to apply forces on thefold that spread the fasteners apart undesirably. In one aspect of thepresent method, tissue is moved from the radially inner layer or side tothe radially outer layer or side of the fold. In this manner, forcesimparted by the fold may be resisted by the radially inner layer. Statedanother way, tissue is moved from the inner layer to the outer layer sothat excess tissue is provided in the radially outer layer relative tothe radially inner layer.

The following method is described in connection with the tissue grasper380 and any of the tissue shapers described herein such as the tissueshaper 308. Upon application of the prior placed fastener F4, control ofthe fold at F4 is maintained with the third section 392 at a controlledposition relative to the prior placed fastener F4 such as directly abovefastener F4. Application of the tissue grasper 380 at the prior fastenerF4 also holds the fold in position for further manipulation.

The tissue shaper 308 (and in particular the tissue displacing element312) is then used to start another fold in anticipation of placingfastener F5 in the direction of fold progression as shown in dotted-lineposition of FIG. 59. The tissue shaper 308 may be rotated beyond theintended fastener site at F5 without fully retracting the tissuedisplacing element 312 so that the stomach tissue begins to wrap arounddevice near the third section 392 of the tissue grasper 308. The fourthsection 394 of the tissue grasper 380 is then positioned at thedotted-line position between the tissue shaper 308 and the prior placedfastener F4 and activated to grasp the radially inner layer at apositioned spaced apart from the prior fastener F4. The prior fastenerF4 and the fourth section 394 are then spread apart to apply tension tothe radially inner layer between the fourth section 394 and the priorfastener F4 thereby potentially reducing excess tissue on the radiallyinner side. Tension is maintained on this portion of tissue untilfastener F5 is applied. Manipulating tissue in this manner may also tendto move tissue from the radially inner side to the radially outer side.

The tissue displacing element 312 may then be retracted further androtated back toward the intended fastener site for F5 (if necessary)while continuing to spread apart tissue on the radially inner sidestepwise or simultaneously. Of course, rotation past the intendedfastener site and stepwise counter-rotation may not be necessarydepending upon the physical characteristics of the stomach tissue andfold shape. The fastener F5 is then applied along the stretched portionof the radially inner layer at a position between the fourth section 394and the prior placed fastener F4. During this process, the tissuegrasper 380 may rotate past one another as shown in FIG. 59.

Referring to FIG. 60, another method is depicted which shifts tissuefrom the radially outer side to the radially inner side. The thirdsection 392 is used to control the tissue adjacent the prior fastener F4and is positioned just above the fastener F4 before releasing the foldafter application of F5. The tissue shaper 308 then displaces tissueinto the stomach to begin the next fold. In doing so, the tissue shaper308 forms the radially inner and outer layers. The fourth section 394 isengaged with the radially inner layer at the dotted-line position ofFIG. 60 and is then moved toward the prior fastener F4 to shift tissuefrom the radially inner layer to the radially outer layer. The tissueshaper 308 may also be moved from the dotted line position toward F7 tofurther shift tissue from the radially outer layer to the radially innerlayer. The tissue shaper 308 is then moved into position to applyfastener F5. The tissue shaper 308 and the fourth section 394 of thetissue grasper 380 may rotate past one another during this process.

In another method in accordance with the present invention, thereinforcing element 410 may be used to reinforce the radially inner sideafter moving tissue from the radially inner side to the outer side. Inthis manner, loads on the folds may be directed to the radially innerlayer if desirable by shifting tissue to the radially outer side and,further, the radially inner side may be supported by the reinforcingelement 410. The reinforcing element 410 is shown extending between F4and F5 and may be applied simultaneous with one or both of the fastenersF4 and F5 or independently as discussed above and incorporated here. Thereinforcing element 410 may also be applied to the radially outer layerusing a separate device to reinforce the area where tissue was shiftedfrom the radially outer side to the radially inner side.

The tissue shapers and tissue graspers of the present invention havebeen described in relation to tissue manipulation aspects of variousprocedures, however, the tissue shapers and tissue graspers will includeother features such as those described in the material incorporated byreference herein. For example, the tissue shapers and/or tissue graspersinclude an endoscope lumen to receive an endoscope (or may have anintegrated visualization device), and one or more lumens forinsufflating and desufflating the stomach as is known in the art.

Although the term fold is used herein to describe the two layerstructures of the present invention, the fold is substantially formed inaccordance with many methods and devices of the present invention bysimply displacing the tissue displacing element. Some unsuccessful priorart solutions attempt to fold the esophagus and stomach together whichis often not possible when the esophagus has shortened due to diseaseprogression. Displacement of the tissue into the stomach substantiallyforms the fold in that the two sides are brought into contact with oneanother typically with only the tissue displacing element even withoutthe tissue shapers of the present invention. The tissue shapers of thepresent invention primarily form the tissue into a desired shape priorto fastening rather than folding the tissue layers together.

Finally, although the terms first, second, third and fourth have beenapplied to the various aspects of the devices for clarity, such as thefirst, second, third and fourth sections of the tissue grasper 380, itis understood, and particularly for the purpose of defining the claims,that any of the enumerated elements may constitute a “first” or “second”section for claim purposes. For example, claims defining the third andfourth sections of tissue grasper 380 may be identified as the “first”and “second” sections in the claims.

The present invention has been described with respect to the preferredembodiment, however, it is understood that numerous modifications couldbe made without departing from the scope of the present invention. Forexample, the tissue shaper 4 may be omitted or could be a user actuatedstructure without departing from the scope of the present invention.

1-50. (canceled)
 51. A method of forming stomach tissue at anintersection of the stomach and the esophagus adjacent the lessercurvature, comprising the steps of: providing a device having a tissueshaper; positioning the tissue shaper in an esophageal tract; engagingstomach tissue with a first tissue displacing element; displacing thestomach tissue into the tissue shaper after the positioning and engagingsteps; applying a fastener through the stomach tissue moved into thefirst tissue shaper with the first tissue displacing elements; andreleasing the stomach tissue after the applying step so that the stomachtissue positioned in the tissue shaper falls back into the stomach. 52.The method of claim 51, wherein: the providing step is carried out withthe open end of the tissue shaper being at a distal end.
 53. The methodof claim 51, wherein: the applying step is carried out to form a foldhaving a convex surface, the convex surface facing inward relative tothe esophagus.
 54. The method of claim 51, wherein: the engaging step iscarried out with the first tissue displacing element extending distallythrough open end and then proximally to engage fundus along the lessercurvature.
 55. The method of claim 51, wherein: the positioning step iscarried out with the tissue shaper being positioned in the esophagealtract; and the applying step being carried out to apply the fastener ata location above the junction between the esophageal tract and thestomach along the greater cruvature side.
 56. The method of claim 55,wherein: the applying step is carried out to apply the fastener at thelocation at least 3 cm above the junction.
 57. The method of claim 51,further comprising the step of: releasing the fold after the applyingstep so that the fold falls back into the stomach and is positioned onthe lesser curvature opposite the junction between the esophageal tractand the stomach along the greater curvature side; the moving step beingcarried out until enough stomach tissue has entered the tissue shaper sothat the fold opposes the junction on the greater curvature side whenreleased.
 58. The method of claim 51, wherein: the applying step iscarried out so that the fold opposes a junction on the greater curvatureside and extends proximally and distally of the junction on the greatercurvature side. 59-76. (canceled)